Clinical Research Coordinator II - Impactful Trials

Rush University Medical Center; Chicago (IL); On-site; USD 37,000 - 54,000; Full time

Job summary

Rush University Medical Center in Oak Park, IL, is seeking a Clinical Research Coordinator II to independently coordinate assigned clinical studies across disciplines. The role includes participant recruitment, data management, regulatory submissions, sponsor communications, and study compliance, with increasing autonomy over time.

Requirements include a Bachelor’s degree and 2+ years coordinating trials, or 3 years in lieu of a degree.

Qualifications

• Bachelor’s degree or equivalent experience in clinical research.
• 2+ years of experience coordinating clinical trials.
• Independent site management experience.

Responsibilities

• Coordinates all aspects of the study including recruitment, consent, screening, scheduling, tracking, and provides study updates to study participants throughout the conduct of the study.
• May collect and enter data into study case report forms and/or electronic data capture system and respond to queries in a timely manner.
• Independently submits or partners with a regulatory coordinator to submit study related documents, study protocols, and protocol amendments to the IRB per policy and procedure, with increasing autonomy over time to prepare for independent regulatory management responsibilities.
• Ensures procedural documentation is accurate, complete, and in compliance with institutional, local, state, and federal guidelines and regulations related to clinical research.
• Verifies and ensures that data is consistent with 100% of source documentation before entry into case report forms and electronic data capture systems to support accuracy, timeliness, and audit readiness.
• May collect, process, and ship potentially biohazardous specimens.
• May administer more complex structured tests and questionnaires according to research study protocols, including providing protocol-specific education to participants.
• Provides ongoing study status updates, responds to questions, and may create summary report(s) for distribution to the PI, Administrator, department stakeholders, Sponsor, and Compliance throughout the conduct of the study.
• Organizes and participates in auditing and monitoring visits.
• Monitors participant interactions for protocol deviations, adverse events (AEs), and serious adverse events (SAEs), and reports findings per institutional and regulatory guidelines.
• Partners with PI(s), sponsor, compliance, clinical staff, and manager to identify and improve more complex processes as it relates to the conduct of the research study.
• May provide oversight, training, and coaching to less experienced staff.
• Other duties as assigned.

Skills

Clinical research coordination

Regulatory knowledge

GCP familiarity

Data entry / EDC

Communication skills

Teamwork

Travel readiness

Education

Bachelor’s degree

Job description

Rush University Medical Center in Oak Park, IL, is seeking a Clinical Research Coordinator II to independently coordinate assigned clinical studies across disciplines. The role includes participant recruitment, data management, regulatory submissions, sponsor communications, and study compliance, with increasing autonomy over time.

Requirements include a Bachelor’s degree and 2+ years coordinating trials, or 3 years in lieu of a degree.